Aprobarbital

Current Scheduling Status
None
Year(s) and type of review / ECDD meetings
Drug Class
ECDD Recommendation
Scheduling/control not currently recommended
Recommendation (from TRS)
Substance identification
Aprobarbital (INN, CAS-77-02-1), chemically 5-allyl-5-isopropylbarbituric acid or allvlisopropylmalonylurea, is also known as allypropymal, allypropymalum, aprobarbitalum, and aprobarbitone. The substance is a racemic mixture.

Similarity to known substances and effects on the CNS
Aprobarbital has been classified pharmacologically as an intermediate-acting sedative-hypnotic barbiturate with a profile similar to that of pentobarbital. As it is a hypnotic, it is presumed. that dose-related drowsiness, vertigo. confusion, and incoordination can occur. The drug, like other barbiturates, is metabolized by

hepatic microsomal enzymes and stimulates the production of these enzymes.

The drug produces typical barbiturate-like sedative-hypnotic effects on the central nervous system. As it is a hypnotic, it ispresumed that tolerance, both natural and: functional, can occur. Cross-tolerance may occur to other barbiturates, ethanol, and other sedative—hypnotic drugs.

Dependence potential
There is no specific information available on the ability of aprobarbital to induce physical of psychic dependence, in either animals or man in controlled laboratory studies.

Actual abuse and or/evidence of likelihood of abuse
There have been sporadic reports on the abuse of aprobarbital from Finland, Federal Republic of Germany, -Norway, and the United States of America: These reports. have mainly concerned combination preparations and no government has reported any public health or social problems caused by this substance. Seven countries reported that the drug is under national. control. There have been reports of seizures of small amounts of the drug from Norway and the United States of America. The Federal Republic of Germany reported a few punishable offences involving aprobarbital from 1982 to 1984.

Therapeutic usefulness
Aprobarbital is used as a sedative and hypnotic and has the same efficacy as other barbiturates in this regard. The drug or combination products containing it have been reported to be

registered and/or available on the market in thirteen countries. Over the past two years modest amounts of the drug have been consumed.

Recommendation
The Committee found that there. was insufficient evidence that aprobarbital is being, or-is likely to be, abused so as to constitute a public health and social problem warranting the placing of the substance under international control. On the basis: of the limited data concerning its pharmacological profile, dependence potential, and actual abuse, the Committee rated

the likelihood of abuse of aprobarbital as. moderate. The degree of the public. health and social problems associated with the drug was found to be low. The Committee rated the therapeutic usefulness of aprobarbital to be relatively low. In the light of this assessment, the Committee recommended against scheduling of the drug.